Post-Market CorPath Registry on the CorPath 200 System in Percutaneous Coronary Interventions

N/ACompletedNCT01917682

Siemens Healthineers Endovascular Robotics, Inc.754 enrolled

Overview

To collect data on the routine patterns of use, safety and effectiveness, including the clinical and technical performance of the CorPath 200 System, in the delivery and manipulation of coronary guidewires and stent/balloon catheters during PCI procedures.

This is a prospective, single-arm, open-label, multi-center patient registry of the CorPath 200 System to examine its performance during PCI procedure and patient outcomes through 72 hours post-procedure or hospital discharge, whichever occurs first.

Study Type

OBSERVATIONAL

Enrollment

754

Conditions

Coronary Artery Disease Coronary Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age \>18 years. 2. Patients with coronary artery disease undergoing Percutaneous Coronary Intervention (PCI) with the CorPath 200 system. 3. The subject or the legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. Exclusion Criteria: 1. Concurrent enrollment in another device or drug study protocol that specifically excludes concurrent enrollment or that prevents collection of data required in this registry (concurrent participation in another registry is not an automatic exclusion criterion for this study). 2. Failure/inability/unwillingness to provide informed consent.

Locations (16)

UC San Diego Medical Center

San Diego, California, United States

Valley View Hospital

Glenwood Springs, Colorado, United States

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

Orlando Regional Medical Center

Orlando, Florida, United States

North Georgia Heart Foundation

Gainesville, Georgia, United States

St. Elizabeth's Medical Center

Boston, Massachusetts, United States

Spectrum Health System

Grand Rapids, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Columbia University Medical Center/New York-Presbyterian Hospital

New York, New York, United States

St. Joseph's Hospital Health Center

Syracuse, New York, United States

...and 6 more locations

Outcomes

Primary Outcomes

Number of Participants With Clinical Success

Less than 30% residual stenosis post PCI in the lesion(s) treated with the CorPath system, without in-hospital major adverse coronary events (MACE).

Time frame: In-hospital (72-hours or discharge, whichever occurs first)

Secondary Outcomes

Number of Participants With In-hospital Major Adverse Coronary Events (MACE)

The composite of death, myocardial infarction, and target vessel revascularization that occurs within 72 hours of the procedure or prior to hospital discharge, whichever occurs first, in a subject treated with the CorPath 200 System.

Time frame: In-hospital (72-hours or discharge, whichever occurs first)

Number of Participants With an Adverse Event

All Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs) from the start of the CorPath procedure until the end of the study will be summarized.

Time frame: In-hospital (72-hours or discharge, whichever occurs first)